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Recruiting NCT07513051

NCT07513051 DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)

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Clinical Trial Summary
NCT ID NCT07513051
Status Recruiting
Phase
Sponsor Centre Hospitalier Intercommunal Creteil
Condition Neonatal Respiratory Distress
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2026-06-10
Primary Completion 2026-06-12

Eligibility & Interventions

Sex All sexes
Min Age 72 Hours
Max Age 10 Weeks
Study Type INTERVENTIONAL
Interventions
CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAPVF-CPAP; VF-CPAP; CF-CPAP; CF-CPAPCF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 20 participants in total. It began in 2026-06-10 with a primary completion date of 2026-06-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The hypothesis behind the study is that the performance of constant flow CPAP (Continuous Positive Airway Pressure) devices (CF-CPAP) is not inferior to that of variable flow CPAP devices (VF-CPAP) in terms of respiratory efforts assessed by swing EAdi (Electrical activity of diaphragm) in a population of premature neonates born ≤ 32 weeks of gestational age.

Eligibility Criteria

Above mentioned age limits (72 hours to 10 weeks) apply to postnatal age. Inclusion criteria apply to gestational age at birth and postmenstrual age (in weeks). Inclusion Criteria: * Neonates born at ≤ 32 weeks GA (gestational age) * Hospitalized in our tertiary hospital NICU (Neonatal intensive care unit) * Receiving CPAP since \> 24 hours at inclusion * Equipped with EAdi catheters. * Aged more than 72 hours * With parental consent * Affiliated to or benefiting from a social security system Non inclusion Criteria: * More than 1 episode of apnea / hour and/or hypercapnic acidosis (defined as pH \< 7.20 and/or pCO2 \> 65) * FiO2 \> 60% * Neonatal ARDS (acute respiratory distress syndrome) according to the Montreux definition * Pneumothorax/ pneumomediastinum * Nasal lesions contraindicating nasal noninvasive ventilation * Major congenital malformation/Chromosomopathies * Congenital neuromuscular diseases * Hemodynamic instability

Contact & Investigator

Central Contact

Xavier DURRMEYER, MD, PhD

✉ Durrmeyer.xavier@chicreteil.fr

📞 0157023468

Frequently Asked Questions

Who can join the NCT07513051 clinical trial?

This trial is open to participants of all sexes, aged 72 Hours or older, up to 10 Weeks, studying Neonatal Respiratory Distress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07513051 currently recruiting?

Yes, NCT07513051 is actively recruiting participants. Contact the research team at Durrmeyer.xavier@chicreteil.fr for enrollment information.

Where is the NCT07513051 trial being conducted?

This trial is being conducted at Créteil, France.

Who is sponsoring the NCT07513051 clinical trial?

NCT07513051 is sponsored by Centre Hospitalier Intercommunal Creteil. The trial plans to enroll 20 participants.

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